i-Lumen Scientific said it has received an Investigational Device Exemption from the US Food and Drug Administration (FDA) to begin US enrollment in the i-SIGHT2 pivotal trial evaluating a bioelectric stimulation therapy for intermediate to advanced dry age-related macular degeneration (AMD). The study, which is already enrolling patients in the United Kingdom, Australia, and New Zealand, is expected to include 120 participants globally. According to the company, US enrollment is anticipated to begin in late April 2026. The first participant has been randomized and treated in the United Kingdom.

The i-SIGHT2 trial is designed to assess the effect of a noninvasive, office-based microcurrent stimulation therapy on visual acuity in patients with vision loss due to dry AMD. The therapy is intended to modulate retinal electrophysiology and improve retinal pigment epithelium function, a key component of disease progression. The study’s primary outcome focuses on visual acuity, with results expected to inform potential regulatory submissions if safety and efficacy thresholds are met.

The device remains investigational and is not approved for commercial use in the United States. Investigators said expansion into the United States may facilitate broader evaluation across diverse patient populations. RP